Company Description Open Scientific provides contract staffing and direct hire recruitment services for the scientific, engineering, laboratory and manufacturing sectors. Job Description This job is located in South Miami Responsibilities • Prepares Stability Reports for FDA Annual Reports and Annual Product Reviews. • Prepares Stability Protocols for Annual and Special Studies. • Enters or approves LIMs protocols utilizing LabWare LIMs. • Monitor and performs trending for stability studies using statistical tools as appropriate. • Prepares Change Controls and Investigations as required in support of the Stability Program. • Participates in Change Control Review Board and assess changes impacting product stability • Performs annual lot tracking and coordinates with appropriate departments the selection of stability samples. • Reviews and approves stability data based on product trending. • Assist the Stability Technician in sample pulling as required. Qualifications • Minimum of Bachelor’s degree in chemistry or related field. • Five or more years of appropriate professional experience preferably in a similar position (Stability Specialist) or in the QA/Technical Services and/or Manufacturing areas. • Knowledge on Stability Program requirements. . • Good written English and verbal communication skills. • Must be highly organized and able to work under pressure. • Must have strong interpersonal and leadership skills. • Must be computer literate with knowledge in all Microsoft business applications. • A strong background in software such as LabWare LIMS and statistical software a plus. Additional Information All your information will be kept confidential according to EEO guidelines.